E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
cirrhosis and portal hypertension |
cirrose og portal hypertension |
|
E.1.1.1 | Medical condition in easily understood language |
Liver sickness |
leversygdom |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10036201 |
E.1.2 | Term | Portal hypertensions |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009211 |
E.1.2 | Term | Cirrhosis liver |
E.1.2 | System Organ Class | 100000004871 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objective of the study is to investigate if Metformin lowers portal blood pressure in patients with cirrhosis.
|
Formålet med studiet er at undersøge om Metformin har gavnlige effekter hos patienter med cirrose og portal hypertension. |
|
E.2.2 | Secondary objectives of the trial |
The effect/changes of Metformin on intestine and liver
|
Effekten/forandringerne af Metformin på tarm og lever. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-age> 18 years -diagnosed with cirrhosis -informed consent -clinical indication for liver vein catherisation (LVC) and/or transjugular intrahepatic portosystemic shunt (TIPS)
|
-alder> 18 years -diagnose med cirrose -informeret samtykke -klinisk indikation for levervenekaterisation (LVK) og/eller transjugulær intrahepatisk portosystemisk shunt (TIPS) |
|
E.4 | Principal exclusion criteria |
servere liver disease (Child Pugh class 12-15) pregnancy incable to understand or read Danish side effects og allergies to Metformin
|
Danish 1. Svær leverinsufficiens CP-klasse C 12-15 2. Graviditet 3. Taler eller forstår ikke dansk 4. Bivirkninger til eller kontraindikation mod Metformin |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes in portal pressure during LVC (Metformin vs placebo) Changes in Plasma lactate concentration in v. porta before/after Metformin |
Ændring i portaltryk ved LVK (Metformin vs placebo) Ændring i laktatkoncentration før/efter Metformin |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
90 minutes after oral consumption
|
90 minutter efter oralt indtag |
|
E.5.2 | Secondary end point(s) |
Metabolic changes in the intestine (arterial blood - v. porta) and liver (v. porta - v. hepatica): Lactate, glucose, purovate, ketones, H+(pH), cytokines, Metformin, TNF- α, insulin, glucagon, GLP-1, GIP, VIP, ammonium, FGF-21 and amino acids.
|
Metaboliske ændringer i tarm (arteriel blod - v. porta) og lever (v. porta - v. hepatica): Laktat, glukose, purovat, ketoner, H+(pH), cytokiner, Metformin, TNF- α, insulin, glucagon, GLP-1, GIP, VIP, ammonium, FGF-21 og aminosyrekoncentrationer. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
90 minutes after oral consumption
|
90 minutter efter oralt indtag |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
32 patients will be included total (16 in each group) + 12 patients undergoing TIPS. |
32 patienter inkluderes (16 i hver gruppe) + 12 patienter der skal have lavet TIPS |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |